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NCT Number: NCT07083778

Comparison Between Laser and Open Fistula Surgeries in the Management of Fistula - In - Ano

This prospective randomized controlled trial compared the outcomes of laser versus open surgical techniques in the management of fistula-in-ano among 100 patients at a tertiary care center. Patients were diagnosed with intersphincteric or transsphincteric fistulas using clinical examination and MR fistulogram and were randomly assigned to undergo either laser surgery (n=50) or open surgery (n=50).

The primary endpoints included postoperative pain, hospital stay duration, and time to return to normal activity. Secondary outcomes assessed were recurrence, wound infection, incontinence, need for reoperation, and patient satisfaction.

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Key information

Conditions

Fistula in Ano Digestive System Diseases Digestive System Fistula Disease Attributes Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Rectal Fistula Recurrence Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kamal Raj

Kanpur, Uttar Pradesh, 208002, India

About this study

This is a prospective, randomized, open-label, parallel-group interventional clinical trial conducted at GSVM Medical College, Kanpur, aimed at comparing the clinical efficacy and safety of laser surgery using the FiLaC (Fistula Laser Closure) technique versus conventional open surgical procedures (fistulotomy or fistulectomy) in the management of fistula-in-ano.

A total of 100 adult patients (>18 years), with a confirmed diagnosis of intersphincteric or transsphincteric fistula-in-ano based on clinical evaluation and magnetic resonance (MR) fistulogram, were enrolled. Following informed consent and screening, patients were randomized in a 1:1 ratio into two arms:

Group A (Laser Surgery Group): Underwent minimally invasive FiLaC procedure using a 1470 nm diode laser and radial fiber probe for endofistular ablation.

Group B (Open Surgery Group): Underwent traditional open surgical procedures including fistulotomy, fistulectomy, or LIFT (Ligation of Intersphincteric Fistula Tract), depending on fistula anatomy.

All surgeries were performed under spinal anesthesia. Postoperative care was standardized across both groups. Patients were followed for a minimum of 3 months with structured clinical assessments at regular intervals.

Primary outcome measures included:

Postoperative pain (VAS score within 7 days)

Duration of hospital stay

Time to resume normal daily activity

Secondary outcomes evaluated were:

Recurrence rate at 3 months

Complete healing within 3 months (closure of both internal and external openings, cessation of discharge)

Anal incontinence rate

Anal stenosis rate

The study intends to assess whether the laser approach offers a meaningful improvement in postoperative morbidity, patient comfort, and quality of life, while also examining risk factors associated with poor surgical outcomes or recurrence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Patient with intersphincter & transphincter fistula in ano as confirmed by clinical examination followed by MR fistulogram.
  • Age 18 to 65 years
  • Non responders and Recurrent Patient giving written informed consent of selected fistula surgery and having awareness about alternative procedures.

Exclusion criteria

  • • Pregnant women
  • Patients of fistula in ano associated with other conditions(HIV, tubercular disease, IBD, Ca rectum.)

Treatment and study plan

Laser Fistula Surgery (FiLaC - Fistula-tract Laser Closure)

Procedure

A minimally invasive procedure using a radial fiber diode laser probe to ablate the fistula tract. Laser energy (10W in pulsed mode) is applied circumferentially as the probe is slowly withdrawn, leading to shrinkage and closure of the fistula tract. The internal opening is closed with absorbable sutures. The procedure is done under spinal or general anesthesia.

Open Fistula Surgery (Fistulotomy, Fistulectomy, or LIFT Procedure)

Procedure

Patients in this group will undergo standard open surgical treatment for fistula-in-ano. Based on the type and location of the fistula (intersphincteric or transsphincteric), the surgical procedure may be:

  • Fistulotomy: Laying open the fistula tract.
  • Fistulectomy: Excision of the entire fistulous tract.
  • LIFT Procedure: Ligation of the intersphincteric fistula tract, preserving the sphincter complex. This sphincter-sparing technique is chosen for transsphincteric fistulas when appropriate.

All procedures are performed under spinal anesthesia. The choice of technique is individualized based on MR fistulogram findings and intraoperative assessment. Wounds are managed with regular dressings and allowed to heal by secondary intention. Standard postoperative care includes antibiotics, analgesia, and sitz baths. Follow-up is done at 1 week, 1 month, 3 months, and 6 months.

Primary outcomes

  1. Postoperative Pain at 48 Hours

    Time frame: 48 hours post-surgery

    Assessment of postoperative pain using the Visual Analogue Scale (VAS) scored from 0 (no pain) to 10 (worst pain imaginable), recorded at 48 hours after surgery.

  2. Length of Hospital Stay

    Time frame: From day of surgery to discharge (typically within 7 days)

    Total number of days the patient remains admitted in the hospital from the day of surgery until discharge.

  3. Time to Return to Normal Work

    Time frame: Within 6 weeks post-surgery

    Number of days taken by the patient to resume normal daily activities or work, as self-reported during follow-up visits.

Secondary outcomes

  1. Fistula Recurrence Rate

    Time frame: Between 16 to 20 weeks post-surgery

    Proportion of patients showing recurrence of fistula-in-ano after surgery, confirmed clinically or radiologically.

  2. Time to Complete Healing

    Time frame: Within 3 months post-surgery

    Number of days from surgery to complete wound healing, defined as epithelialization of the surgical site without discharge.

  3. Anal Incontinence Rate (Wexner Score)

    Time frame: Assessed at each follow-up up to 6 months

    Incidence of anal incontinence assessed using the Wexner Incontinence Score, a validated scale ranging from 0 (perfect continence) to 20 (complete incontinence).

  4. Anal Stenosis Rate

    Time frame: Within 3 months post-surgery

    Proportion of patients developing clinically significant anal stenosis, defined as narrowing of the anal canal requiring intervention or causing obstructive symptoms.

Sponsors and collaborators

Lead sponsor

GSVM Medical College

Other

Registry information

Official study title

A Randomized Controlled Trial to Determine the Efficacy and Safety of Laser Versus Open Surgery in the Treatment of Fistula-in-Ano at a Tertiary Care Centre

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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